MAUDE Adverse Event Report: CODAN US CORP NONE; MICROBORE EXTENSION TUBING

Model Number BC 518

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 08/03/2019

Event Type  malfunction  

Event Description

The patient is epoprostenol dependent.The medication was being delivered at 0.7 ml/hr by the medfusion 3500 microinfusion pump using a 60 ml syringe with a luerlock tip attached to a microbore extension set.The patient had traveled to the cardiac catheterization laboratory and upon return, the pump, medication and iv site were assessed, and all appeared to be functioning appropriately.Approximately 4 hours later the nurse noted drops of fluid on the top of the pump as well as within the bag used to protect the epoprostenol from light.Examination of the tubing revealed a crack in the extension set at the connection between the tubing and the syringe.Because of the small volume being infused, it is difficult to determine when and how the crack occurred.The epoprostenol was restarted with a new syringe and tubing and the patient became flushed and relatively tachycardic and hypotensive and was quickly stabilized but was transferred to the cardiac intensive care unit, for closer monitoring.

• Brand Name: NONE
• Type of Device: MICROBORE EXTENSION TUBING
• Manufacturer (Section D): CODAN US CORP; 3511 west sunflower avenue; santa ana CA 92704
• MDR Report Key: 8939433
• MDR Text Key: 155844408
• Report Number: 8939433
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BC 518
• Device Catalogue Number: 72.7960
• Device Lot Number: 78604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18615 DA
• Patient Weight: 96